Penny Kusumastuti Lukito, the head of Indonesia's Food and Drug Control Agency (BPOM), at the 2018 BPOM national evaluation meeting in Bali on Nov. 27, 2018. (Antara Photo/Fikri Yusuf)
BPOM Gives Nod for Clinical Trials on Ivermectin as Covid-19 Treatment
BY :JAKARTA GLOBE
JUNE 28, 2021
Jakarta. The National Food and Drug Control Agency, or BPOM, has given the green light to conduct clinical trials on the use of anti-parasitic drug Ivermectin to treat Covid-19 patients.
In an official statement released in March, the World Health Organization (WHO) advised Ivermectin to be only used for Covid-19 treatments within clinical trials.
“BPOM is on the same page as WHO by facilitating an immediate clinical trial initiated by the Health Ministry’s Research and Development Agency. This enables immediate, wide public access to the drug within clinical trials,” BPOM head Penny Lukito said in a statement on Monday.
According to Penny, several global publications have shown Ivermectin’s use for Covid-19 treatments. She, however, warned its current use is limited to clinical trials in accordance with WHO’s guidelines.
Other drug control authorities with good regulatory systems —such as the US Food and Drug Administration (FDA) as well as European Medicines Agency (EMA)– are also like-minded, as the current clinical trial data on Ivermectin as a Covid-19 drug is still inconclusive, she said.
Indonesia lists Ivermectin as an antiparasitic, prescription-only medicine. Doctors can prescribe Ivermectin to those who are in need of the drug, but not a part of the clinical trial. They, however, must ensure its use complies with the approved protocols for clinical trials.
About eight hospitals will take part in the clinical trials to see the efficacy and safety of Ivermectin for Covid-19, including RSUD dr. Soedarso in Pontianak and RSUP H. Adam Malik in Medan.
Six Jakarta-based hospitals will join in the testing, namely RSUP Persahabatan, RSUP Prof. Dr. Sulianti Saroso, RSPAD Gatot Soebroto, RSAU Dr. Esnawan Antariksa, RS dr. Suyoto or the Defense Ministry's rehabilitation center, and RSDC Wisma Atlet.
BPOM will continue to keep tabs on the clinical trial and its results. BPOM will also look out for the latest information on Ivermectin by communicating with the WHO and other drug authorities, Penny noted.
"For safety, BPOM warns the public against purchasing Ivermectin without a doctor's prescription, including buying it via an online platform," she said.
Indonesian Medical Association (IDI) chairman Daeng M Faqih welcomed BPOM’s approval on Ivermectin clinical trials. He said “this is in line with WHO and the US FDA recommendations.”
According to State-Owned Enterprises Minister Erick Thohir, Indonesia is ready to produce up to 4.5 million tablets a month if the clinical trial shows positive results.
“If it is good for all of us, we will boost the production,” he said.
The minister also ensured enough supplies for other medications such as Oseltamivir, Favipiravir and Remdesivir. As for Covid-19 shots, the government is also sparing no efforts to secure vaccine supply be it from other countries or developing a homegrown vaccine commonly known as the "Merah Putih" vaccine.
"We managed to vaccinate 1.3 million people within a day the other day. We must keep this up," Erick said.